EP1962919A1 - Textiles revetus - Google Patents

Textiles revetus

Info

Publication number
EP1962919A1
EP1962919A1 EP06829807A EP06829807A EP1962919A1 EP 1962919 A1 EP1962919 A1 EP 1962919A1 EP 06829807 A EP06829807 A EP 06829807A EP 06829807 A EP06829807 A EP 06829807A EP 1962919 A1 EP1962919 A1 EP 1962919A1
Authority
EP
European Patent Office
Prior art keywords
textile
textile material
coating
hydrogels
implant
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP06829807A
Other languages
German (de)
English (en)
Inventor
Niels A. Abt
Guido Casutt
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Zimmer GmbH
Original Assignee
Zimmer GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Zimmer GmbH filed Critical Zimmer GmbH
Priority to EP06829807A priority Critical patent/EP1962919A1/fr
Publication of EP1962919A1 publication Critical patent/EP1962919A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28Materials for coating prostheses
    • A61L27/34Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/441Joints for the spine, e.g. vertebrae, spinal discs made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4455Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/52Hydrogels or hydrocolloids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08Materials for coatings
    • A61L29/085Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/145Hydrogels or hydrocolloids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442Intervertebral or spinal discs, e.g. resilient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006Properties of materials and coating materials
    • A61F2002/30062(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108Shapes
    • A61F2002/30199Three-dimensional shapes
    • A61F2002/302Three-dimensional shapes toroidal, e.g. rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442Intervertebral or spinal discs, e.g. resilient
    • A61F2002/444Intervertebral or spinal discs, e.g. resilient for replacing the nucleus pulposus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2002/4495Joints for the spine, e.g. vertebrae, spinal discs having a fabric structure, e.g. made from wires or fibres
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0065Three-dimensional shapes toroidal, e.g. ring-shaped, doughnut-shaped
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00353Bone cement, e.g. polymethylmethacrylate or PMMA
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00Stock material or miscellaneous articles
    • Y10T428/13Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1334Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00Stock material or miscellaneous articles
    • Y10T428/13Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352Polymer or resin containing [i.e., natural or synthetic]
    • Y10T428/139Open-ended, self-supporting conduit, cylinder, or tube-type article
    • Y10T428/1393Multilayer [continuous layer]
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T442/00Fabric [woven, knitted, or nonwoven textile or cloth, etc.]
    • Y10T442/20Coated or impregnated woven, knit, or nonwoven fabric which is not [a] associated with another preformed layer or fiber layer or, [b] with respect to woven and knit, characterized, respectively, by a particular or differential weave or knit, wherein the coating or impregnation is neither a foamed material nor a free metal or alloy layer
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T442/00Fabric [woven, knitted, or nonwoven textile or cloth, etc.]
    • Y10T442/20Coated or impregnated woven, knit, or nonwoven fabric which is not [a] associated with another preformed layer or fiber layer or, [b] with respect to woven and knit, characterized, respectively, by a particular or differential weave or knit, wherein the coating or impregnation is neither a foamed material nor a free metal or alloy layer
    • Y10T442/2861Coated or impregnated synthetic organic fiber fabric
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T442/00Fabric [woven, knitted, or nonwoven textile or cloth, etc.]
    • Y10T442/20Coated or impregnated woven, knit, or nonwoven fabric which is not [a] associated with another preformed layer or fiber layer or, [b] with respect to woven and knit, characterized, respectively, by a particular or differential weave or knit, wherein the coating or impregnation is neither a foamed material nor a free metal or alloy layer
    • Y10T442/2861Coated or impregnated synthetic organic fiber fabric
    • Y10T442/2877Coated or impregnated polyvinyl alcohol fiber fabric
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T442/00Fabric [woven, knitted, or nonwoven textile or cloth, etc.]
    • Y10T442/20Coated or impregnated woven, knit, or nonwoven fabric which is not [a] associated with another preformed layer or fiber layer or, [b] with respect to woven and knit, characterized, respectively, by a particular or differential weave or knit, wherein the coating or impregnation is neither a foamed material nor a free metal or alloy layer
    • Y10T442/2861Coated or impregnated synthetic organic fiber fabric
    • Y10T442/291Coated or impregnated polyolefin fiber fabric
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T442/00Fabric [woven, knitted, or nonwoven textile or cloth, etc.]
    • Y10T442/20Coated or impregnated woven, knit, or nonwoven fabric which is not [a] associated with another preformed layer or fiber layer or, [b] with respect to woven and knit, characterized, respectively, by a particular or differential weave or knit, wherein the coating or impregnation is neither a foamed material nor a free metal or alloy layer
    • Y10T442/2926Coated or impregnated inorganic fiber fabric

Definitions

  • the present invention relates to a textile material comprising a textile substrate, wherein a coating is provided at least on a part of the surface of the textile substrate. Furthermore, the present invention relates to a method for producing such a textile material, an article, in particular implant, as well as the use of the object RPg.
  • Textile materials are used in many technical fields, such as automotive, apparel, construction, and medical.
  • the technical properties of the textile materials can be adapted to the specific requirements of future use by selecting suitable textile fiber materials, adding suitable auxiliaries and applying a coating of suitable material.
  • textile materials are today used in a variety of ways, in particular in the medical field, for example as a material for hygiene articles, filters, wound dressings, carrier and support materials, surgical sutures and implants.
  • Implants made of textile materials have proven useful, for example, as an artificial intervertebral disc and spinal column implants.
  • a human spine comprises 23 intervertebral discs, which, like a pillow, are located between two adjoining cortical cancellous bone. lying vertebrae lie.
  • each intervertebral disc consists of three different components, which together form a functional unit, namely a nucleigelatin nucleus (nucleus pulposus) lying in the center of the intervertebral disc, a fibular cartilage ring (annulus fibrosus) surrounding the nucleus, and two each on the cover.
  • the core or fibrocartilage ring consisting of hyaline cartilage end plates which fit tightly against the adjacent vertebral bodies.
  • the end plates form a transition zone between the disc with its soft core and the adjacent, hard vertebral bodies. If one of the end plates is destroyed, core tissue can penetrate into the vertebral body, so that the core can no longer function as a pressure pad. Breaking the intervertebral disc, in turn, may cause the nucleus pulposus to leak through a fracture site in the fibrocartilage ring, causing pressures against the ganglia or spinal cord nerve and causing severe pain in both the back and legs.
  • each of the aforementioned implants usually consists of an envelope of textile material filled with a filler.
  • Such an implant which consists of a high-strength, with the human body tissue compatible wire or fiber fabric, such as a titanium fabric, and can be filled with a suitable fluid as filler, is known for example from EP 0 480 954 Bl.
  • US 2002/0029083 A1 discloses an implant for an artificial disc which comprises a layer of a keratin material, for example a keratin hydrogel, and optionally a further layer of a polymer, for example polyethylene, polytetrafluoroethylene, polystyrene or the like, includes.
  • a keratin material for example a keratin hydrogel
  • a polymer for example polyethylene, polytetrafluoroethylene, polystyrene or the like
  • tubes which, among other things, introduce viscous fluids into the human body.
  • An example of this are tubes, over which filling material can be introduced into implants already inserted into the body.
  • Another example is vertebroplasty for the treatment of osteoporosis.
  • viscous bone cement is injected into the porous bone via a tubing connected at one end to a cannula to fill the bone with the bone cement for internal stabilization. Due to the high viscosity of the bone cement tubing must be used with a sufficiently large inside diameter to ensure adequate promotion of the bone cement through the tube.
  • the hoses must have a sufficient impermeability to the material to be conveyed, in order to prevent a passage of the conveyed material, for example bone zemerite, out of the hose into the interior of the body.
  • the currently known textile materials from which such tubes are made are not sufficiently impermeable to the materials to be conveyed. The sliding properties of the known textile materials are in need of improvement.
  • a textile material is to be provided which has sufficient gliding properties and, in particular, in relation to intervertebral disc and vertebral body Implants commonly used impermeable and therefore can be used advantageously in the medical field as tubing, for example, for vertebroplasty, or as an implant material, for example, for a nucleus replacement.
  • the textile material and its coating should have good biostability.
  • a textile material comprising a textile substrate, wherein at least a portion of the surface of the textile substrate is provided with a coating comprising one of hydrogel-excluded keratin hydrogels, polyurethanes, polyvinyl chloride, polytetrafluoroethylene, and any of Combinations of two or more of the aforementioned compounds selected compound or consists of one of the aforementioned compounds.
  • textile substrates coated with a compound selected from the group consisting of hydrogels other than keratin hydrogels, polyurethanes, polyvinyl chloride, polytetrafluoroethylene and any combination of two or more of the aforementioned compounds have excellent impermeability compared to fillers used in the medical field, such as bone cement, and also characterized by good sliding properties shafts. Furthermore, these materials have excellent biostability and reproducible quality, so that the cost of quality control in the manufacture of these materials can be limited.
  • the textile materials can advantageously be used as material for implants, for example an artificial intervertebral disc, replacement of the nucleus pulposus, cage, vertebral disc.
  • hydrogel means, in accordance with the relevant technical literature, a water-containing, but water-insoluble polymer whose molecules are chemically or physically linked to form a three-dimensional network.
  • a part or the entire surface of the textile substrate may be coated with the material described above.
  • a textile material comprising a textile substrate is proposed in which the textile substrate consists of fibers and at least a part of the fibers is provided with a coating which consists of one of synthetic hydrogels, polyurethanes, polyvinyl chloride, polytetrafluoroethylene and any combination of containing two or more of the aforementioned compounds selected compound or consists of one of the aforementioned compounds. Due to the use of synthetic coating materials, the corresponding textile materials have excellent biostability and a reproducible quality, which means that the expense of quality control in the production of the corresponding materials can be limited.
  • the present invention is not limited in the chemical nature of the synthetic hydrogel and the number of hydrogels contained in the coating.
  • the coating of the textile substrate can be a synthetic one Hydrogel or at least two different synthetic hydrogels, wherein the coating can contain other auxiliaries and additives in addition to the at least one synthetic hydrogel.
  • Particularly good results are obtained when the coating of the textile substrate consists of one or at least two different synthetic hydrogels.
  • Such materials have a particularly high impermeability to filling materials commonly used in the medical field, for example bone cement, as well as good biostability.
  • the coating of the textile substrate contains a hydrogel based on a vinyl polymer or, in particular, consists of a hydrogel based on vinyl polymer.
  • the coating of the textile substrate hydrogels from all vinyl polymers known to the skilled person for this purpose, in particular vinyl polymers which have proven suitable for this purpose, those of polyvinyl alcohol, polyvinyl acetate, polyvinyl butyral, polyvinylpyrrolidone and any desired compounds Mixtures of at least two of the aforementioned compounds group are selected. Particularly good results are obtained when the coating of the textile substrate contains a polyvinyl alcohol hydrogel, or in particular when the coating of the textile substrate consists of a polyvinyl alcohol hydrogel.
  • the coating of the textile material contains a polyurethane and in particular a polycarbonate urethane.
  • the polycarbonate urethane may be composed of both aromatic and aliphatic hard segments. Likewise possible 006/012373
  • polycarbonate urethane is a silicone-terminated polycarbonate urethane.
  • the coating consists of a polyurethane or of a polycarbonate urethane, particularly good results are obtained.
  • polycarbonate urethanes are distinguished by excellent biostability, so that they are particularly suitable as coating material.
  • Polycarbonate urethanes which have a weight-average molecular weight of 60,000 to 500,000 g / mol and in particular 90,000 to 400,000 g / mol have proven particularly suitable as coating materials, the ratio between the hard and soft segments being between 20% / 80% and 60%. / 40% should be.
  • the thickness of the coating provided on the textile substrate of the textile material or of the coating provided on the individual fibers or a part of the fibers of the textile substrate depends in particular on the later intended use of the textile material. In particular, with textile materials having a coating thickness between 0.5 and 200 microns, good results are obtained. In accordance with another exemplary embodiment of the present disclosure, the thickness of the coating is between 0.5 and 50 ⁇ m, and more preferably between 0.5 and 10 ⁇ m. In addition to adequate sliding properties, such coatings also have a high impermeability to filling materials commonly used in the medical field. If the layer thickness is too small, a sufficient impermeability of the textile material to the filling material can not be achieved, whereas if the layer thickness is too great there is a risk that the coating will separate completely or at least partially from the substrate over time. 12373
  • the textile substrate consists of biocompatible and / or resorbable material.
  • the textile substrate consists of a single biocompatible and / or resorbable material, and the case that it consists of a mixture of at least two different, each biocompatible and / or resorbable materials.
  • the textile substrate can be used in the form of a textile composite material, that is to say a textile material which is neither woven nor knitted nor knitted, and / or in the form of a woven fabric, knitted fabric or knitted fabric.
  • suitable textile composites are felts or nonwovens. Good results are obtained, in particular, if a textile substrate is provided in the textile material, which consists of a woven, knitted or knitted textile fabric.
  • the textile substrate consists of a woven, knitted or knitted textile fabric, which is sealed liquid-tight by the coating.
  • the material of the textile substrate forming textile fibers can be freely selected depending on the intended use of the material. Particularly when used as a tube material or as an implant material, it has proven to be advantageous if the textile substrate of the textile material comprises textile fibers of one of polyethylene terephthalate (PET), polyether ketones (PEEK), polymethyl methacrylates (PMMA), titanium (Ti), Cobalt-chromium (CoCr) alloys, hydrogels other than keratin hydrogels, polyvinyl alcohol (PVA), polyolefins, in particular polyethylene (PE) and polypropylene (PP), and any combination of two or more of the foregoing.
  • PET polyethylene terephthalate
  • PEEK polyether ketones
  • PMMA polymethyl methacrylates
  • Ti titanium
  • CoCr Cobalt-chromium
  • hydrogels other than keratin hydrogels polyvinyl alcohol (PVA), polyolefins, in particular polyethylene (PE) and polypropy
  • Such materials are characterized in particular by excellent biocompatibility.
  • Particularly suitable for this purpose is PET.
  • Another object of the present disclosure is a process for producing a textile material, in particular a previously described textile material, wherein a textile substrate at least partially with a of the hydrogels except keratin hydrogels, polyurethanes, in particular polycarbonate urethanes, polyvinyl chloride, polytetrafluoroethylene and any combination of two or more of the aforementioned compounds selected compound is coated.
  • a textile substrate at least partially with a of the hydrogels except keratin hydrogels, polyurethanes, in particular polycarbonate urethanes, polyvinyl chloride, polytetrafluoroethylene and any combination of two or more of the aforementioned compounds selected compound is coated.
  • the method is not limited to individual coating techniques. Rather, the application of the coating on the textile substrate can be done with any known to those skilled in the art for this purpose.
  • the coating of the textile substrate can be achieved, for example, by immersing the textile substrate in a synthetic hydrogel solution and then subjecting the hydrogel solution Substrate provided with the hydrogel solution at least a freeze-thaw cycle.
  • This method has proved to be particularly advantageous if the entire surface or the entire surfaces of the textile substrate are to be coated with a hydrogel.
  • the method explained above is also suitable for only a partial coating of the textile substrate, in which case the parts of the surface which are not to be coated are correspondingly covered.
  • the textile substrate can be applied to a carrier material and immersed in the hydrogel solution with this carrier material, wherein only the surface of the textile substrate opposite the carrier material is coated with the hydrogel.
  • the hydrogel solution into which the textile substrate to be coated is to be immersed, for example one from 2 to 40% by weight and in particular from 5 to 20% by weight.
  • This solution can be prepared, for example, by an appropriate amount of polyvinyl alcohol in an appropriate amount of water at 95 0 C is dissolved.
  • the present invention is not limited. However, it has proved to be advantageous to subject the textile substrate to be coated at least two freeze-thaw cycles and in particular exactly two freeze-thaw cycles. At each of the individual freeze-thaw cycles, the coated substrate is first incubated for a sufficient period of time at temperatures less than 0 ° C to freeze the material. For example, the temperature of the frost stage of the frost-thaw cycle is between -1 73
  • freeze-thaw cycle treatment is to achieve cross-linking between the individual molecules of the hydrogel to increase the shelf life of the hydrogel.
  • Another object of the present invention is an article, in particular an implant, with an outer shell, wherein the outer shell consists of the textile material described above. Due to the coating of the textile substrate of the textile material with a compound selected from the group consisting of hydrogels other than keratin hydrogels, polyurethanes, in particular polycarbonate urethanes, polyvinyl chloride, polytetrafluoroethylene and any combination of two or more of the aforementioned compounds.
  • a compound selected from the group consisting of hydrogels other than keratin hydrogels, polyurethanes, in particular polycarbonate urethanes, polyvinyl chloride, polytetrafluoroethylene and any combination of two or more of the aforementioned compounds Such an article by a high impermeability to commonly used in the medical field filling materials and also by good sliding properties and excellent biostability.
  • the article is designed as a hose. Due to the high degree of impermeability of the textile substrate coated with a lycydrolyte and its good biocompatibility, such a tube is outstandingly suitable for introducing liquids, in particular highly viscous liquids, into the human body, for example introduction of bone cement in vertebroplasty.
  • the article may for example be formed as a ring or balloon-shaped.
  • the tube, ring or balloon can be coated on both sides or on one side with at least one hydrogel. Especially if 12
  • the tube is provided for introducing liquid into a human body, it has proven to be advantageous to coat the tube on both sides or at least the inside of the article with the aforementioned coating, in particular with a hydrogel.
  • a filler is included in the shell of the article, which is enclosed by the shell, in particular on all sides.
  • the filling material may be, for example, bone cement, a synthetic hydrogel and / or Ringer's solution, but the present invention is not limited to any of the aforementioned materials.
  • the article can be used as an artificial intervertebral disc, replacement of the nucleus pulposus, cage, spinal column implant or articular surface replacement - for example filled with bone cement, a synthetic hydrogel and / or Ringer's solution.
  • the article - designed as a tube - can be used in vertebroplasty or nucleoplasty.
  • 1 is a schematic perspective view of a natural human disc
  • 2 shows a schematic perspective view of an intervertebral disc with an implant according to a first exemplary embodiment of the present invention
  • FIG. 3 is a schematic perspective view of an intervertebral disc with an implant according to a second embodiment of the present invention
  • FIG. 4 shows a schematic perspective view of an intervertebral disc with an implant according to a third exemplary embodiment of the present invention
  • FIG. 5 is a schematic perspective view of an intervertebral disc with an implant according to a fourth embodiment of the present invention.
  • FIG. 6 shows a schematic perspective view of an implant according to a fifth exemplary embodiment of the present invention
  • Fig. 7 is a schematic perspective view of an implant according to a sixth Ausfaturigsbcispiel the present
  • FIG. 8 shows a schematic perspective view of a vertebral body with an implant according to a seventh exemplary embodiment of the present invention
  • Fig. 9 is a cross-sectional view of a textile material according to a first embodiment of the present invention and 10 is a cross-sectional view of a textile material according to a second embodiment of the present invention.
  • a fibrous cartilage ring 12 which is composed of highly structured collagen fibers embedded in an amorphous base substance.
  • a fibrous cartilage ring 12 which is composed of highly structured collagen fibers embedded in an amorphous base substance.
  • the soft core occupies about 25-40% of the total cross-section of the disc and is composed mainly of mucoid material containing mainly proteoglycans with a low content of collagen.
  • a vertebral end plate (not shown) is provided in the area of the nucleus pulposus, which are composed of hyaline cartilage mass and separates the intervertebral disk 10 from the adjacent vertebral bodies (not shown).
  • the nucleus pulposus was removed and replaced by a substantially annular implant 16.
  • the interior of the implant 16 was filled with bone or bone substitute material.
  • Such implants which replace only part of the core, are also commonly referred to as cage.
  • FIG. 3 shows an intervertebral disk 10 with a bag-shaped implant 16 '.
  • the implant 16 ' has a tube piece 18 through which the filling material for the implant 16' can be inserted.
  • This filling material may be, for example, bone cement, a hydrogel and / or Ringer's solution.
  • the introduction of the filling material through the hose piece 18 into the implant 16 ' may be made prior to insertion of the implant 16' into or after the patient.
  • the core replacement shown in FIG. 5 consists of a tubular implant 16 '" with a tube piece 18'.
  • FIG. 6 shows a likewise bag-shaped implant 16 "", whose outer shell consists of the textile material with one of the abovementioned coating materials, in particular a hydrogel coating.
  • This implant 16 "" is designed such that it can completely replace an intervertebral disc (artificial intervertebral disc).
  • this implant 16 "” has a piece of tubing 18 "through which filling material, such as Ringer's solution, hydrogel and / or bone cement, can be introduced into the implant 16" ".
  • filling material such as Ringer's solution, hydrogel and / or bone cement
  • the implant 16 '"" shown in FIG. 7 and suitable as an artificial intervertebral disc has a body shaped in cross-section corresponding to the natural intervertebral disc on which two elevations simulating an end plate are provided or which are each provided with on its upper side and underside an end plate is connected.
  • FIG. 8 schematically shows a vertebral body 20 in which an implant 16 """is inserted, and the outer shell of this implant 16""” is made of hydrogel-coated textile material and is connected via a tube piece 18 '"with a
  • Such an implant 16 ""” is useful, for example, in the case of a fracture of the vertebral body, whether caused by trauma or osteoporosis.
  • the textile material 21 shown in FIG. 9 consists of a substantially circular cross-section fiber 22 and a coating 24 applied to the fiber surface
  • the textile material 21 'shown in FIG. 10 comprises a plurality of fibers 22', wherein the entire fiber structure is provided with a coating 24 '.
  • woven PET fibers As they are also used for the manufacture of cords which the dynamic spinal stabilization system Dynesys ® are used, two tubes with an internal diameter of 4 mm and a length of 100 mm were prepared. For coating, these hoses were then immersed in a 10 wt .-% highly hydrolysed polyvinyl alcohol-containing solution prepared by dissolving the appropriate amount of polyvinyl alcohol in water at 95 0 C, to the hoses both on their inner surfaces and on the outer surfaces of the textile substrate with polyvinyl alcohol to coat.
  • the tubes thus coated were then subjected to two freeze-thaw cycles by first incubating the tubes at -17 ° C for 3 days, then incubating for 5 hours at room temperature and thawing them before re-priming the tubes for 12 hours Frozen and then incubated for 2 hours at room temperature. Finally, the hydrogel-coated tubes were conditioned in water for 2 hours. Each of the two tubing so produced was mechanically attached to the top of a 60 ml syringe.
  • the bone cement was mixed for 60 seconds prior to introduction into the syringe and incubated for a further 30 seconds to remove air bubbles.
  • the cement was then filled into the syringe and delivered through the syringe and tube with pressure.
  • the bone cement could be easily transported through both tubes without bone cement penetrating through the tubing.
  • the textile material has excellent impermeability to filling materials commonly used in the medical field, such as bone cement, and has sufficient lubricating properties to promote even highly viscous materials.
  • Example 2 The procedure was the same as in Example 1, except that instead of two tubes coated with polyvinyl alcohol hydrogel, two corresponding but uncoated tubes made of woven PET fibers were used.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Transplantation (AREA)
  • Epidemiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Neurology (AREA)
  • Dispersion Chemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)
  • Treatments For Attaching Organic Compounds To Fibrous Goods (AREA)
  • Woven Fabrics (AREA)

Abstract

L'invention concerne un matériau textile (21, 21') qui comprend un support textile (22, 22') et qui présente au moins sur une partie de la surface du support textile (22, 22') un revêtement (24, 24') qui contient au moins un composé sélectionné dans l'ensemble constitué des hydrogels à l'exception des hydrogels de kératine, des polyuréthanes, du poly(chlorure de vinyle), du poly(tétrafluorure d'éthylène) et des combinaisons quelconques de deux des composés ci-dessus ou plus. Ce matériau textile (21, 21') peut être utilisé en particulier en vertébroplastie ou nucléoplastie comme matériau pour disque intervertébral artificiel (16'', 16'''), remplacement du noyau pulpeux (16', 16''), cage (16, 16'), implant de vertèbre (16'''') ou remplacement de la surface d'articulations ou manchon (18, 18', 18', 18'').
EP06829807A 2005-12-23 2006-12-21 Textiles revetus Withdrawn EP1962919A1 (fr)

Priority Applications (1)

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EP05112978 2005-12-23
CH82006 2006-01-04
EP06829807A EP1962919A1 (fr) 2005-12-23 2006-12-21 Textiles revetus
PCT/EP2006/012373 WO2007076951A1 (fr) 2005-12-23 2006-12-21 Textiles revetus

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JP (1) JP2009520888A (fr)
AU (1) AU2006332156B2 (fr)
CA (1) CA2634514A1 (fr)
WO (1) WO2007076951A1 (fr)

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US8275594B2 (en) * 2006-10-30 2012-09-25 The Regents Of The University Of Michigan Engineered scaffolds for intervertebral disc repair and regeneration and for articulating joint repair and regeneration
US7737059B1 (en) * 2009-02-19 2010-06-15 Milliken & Company Airbag coating
US8795369B1 (en) 2010-07-16 2014-08-05 Nuvasive, Inc. Fracture reduction device and methods
JP2015063763A (ja) * 2012-01-27 2015-04-09 テルモ株式会社 立体織物とその製造方法
US20130282121A1 (en) * 2012-03-22 2013-10-24 Ann Prewett Spinal facet augmentation implant and method
WO2017151714A1 (fr) * 2016-03-01 2017-09-08 Mayo Foundation For Medical Education And Research Système et procédé pour composites polymères renforcés dans des dispositifs médicaux et instrumentation
US20220409387A1 (en) * 2021-06-23 2022-12-29 Oluwatodimu Richard Raji Methods and systems for facilitating treatment of lumbar degenerative disc disease based on total nucleus replacement using magnetic spherical beads

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CH671691A5 (fr) * 1987-01-08 1989-09-29 Sulzer Ag
EP0444382B1 (fr) * 1990-03-01 1994-04-06 SULZER Medizinaltechnik AG Prothèse d'acétabule métallique utilisable sans ciment
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AU2006332156A2 (en) 2008-11-27
CA2634514A1 (fr) 2007-07-12
US20100030284A1 (en) 2010-02-04
AU2006332156B2 (en) 2012-07-05
WO2007076951A1 (fr) 2007-07-12
JP2009520888A (ja) 2009-05-28
AU2006332156A1 (en) 2007-07-12

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